Choline Alphoscerate-Nimodipine in Vascular Cognitive Impairment

Summary

The purpose of this study is to assess whether the combination of choline alphoscerate 1200mg per day and nimodipine 90mg per day given orally is more effective than the combination nimodipine placebo in reducing cognitive decline in patients with subcortical vascular cognitive impairment

Timeline

Start

2017-05-02

Primary completion

2019-07-09

Completion

2019-07-09

Publications

• Background O'Brien JT, Erkinjuntti T, Reisberg B, Roman G, Sawada T, Pantoni L, Bowler JV, Ballard C, DeCarli C, Gorelick PB, Rockwood K, Burns A, Gauthier S, DeKosky ST. Vascular cognitive impairment. Lancet Neurol. 2003 Feb;2(2):89-98. doi: 10.1016/s1474-4422(03)00305-3.
• Background Pantoni L. Cerebral small vessel disease: from pathogenesis and clinical characteristics to therapeutic challenges. Lancet Neurol. 2010 Jul;9(7):689-701. doi: 10.1016/S1474-4422(10)70104-6.
• Background Wardlaw JM, Smith C, Dichgans M. Mechanisms of sporadic cerebral small vessel disease: insights from neuroimaging. Lancet Neurol. 2013 May;12(5):483-97. doi: 10.1016/S1474-4422(13)70060-7.
• Background Wardlaw JM, Smith EE, Biessels GJ, Cordonnier C, Fazekas F, Frayne R, Lindley RI, O'Brien JT, Barkhof F, Benavente OR, Black SE, Brayne C, Breteler M, Chabriat H, Decarli C, de Leeuw FE, Doubal F, Duering M, Fox NC, Greenberg S, Hachinski V, Kilimann I, Mok V, Oostenbrugge Rv, Pantoni L, Speck O, Stephan BC, Teipel S, Viswanathan A, Werring D, Chen C, Smith C, van Buchem M, Norrving B, Gorelick PB, Dichgans M; STandards for ReportIng Vascular changes on nEuroimaging (STRIVE v1). Neuroimaging standards for research into small vessel disease and its contribution to ageing and neurodegeneration. Lancet Neurol. 2013 Aug;12(8):822-38. doi: 10.1016/S1474-4422(13)70124-8.
• Background Pantoni L. Treatment of vascular dementia: evidence from trials with non-cholinergic drugs. J Neurol Sci. 2004 Nov 15;226(1-2):67-70. doi: 10.1016/j.jns.2004.09.014.
• Background Smith EE, Cieslak A, Barber P, Chen J, Chen YW, Donnini I, Edwards JD, Frayne R, Field TS, Hegedus J, Hanganu V, Ismail Z, Kanji J, Nakajima M, Noor R, Peca S, Sahlas D, Sharma M, Sposato LA, Swartz RH, Zerna C, Black SE, Hachinski V. Therapeutic Strategies and Drug Development for Vascular Cognitive Impairment. J Am Heart Assoc. 2017 May 5;6(5):e005568. doi: 10.1161/JAHA.117.005568. No abstract available.
• Background Di Perri R, Coppola G, Ambrosio LA, Grasso A, Puca FM, Rizzo M. A multicentre trial to evaluate the efficacy and tolerability of alpha-glycerylphosphorylcholine versus cytosine diphosphocholine in patients with vascular dementia. J Int Med Res. 1991 Jul-Aug;19(4):330-41. doi: 10.1177/030006059101900406.
• Background Pantoni L, Carosi M, Amigoni S, Mascalchi M, Inzitari D. A preliminary open trial with nimodipine in patients with cognitive impairment and leukoaraiosis. Clin Neuropharmacol. 1996 Dec;19(6):497-506. doi: 10.1097/00002826-199619060-00003.
• Background Pantoni L, del Ser T, Soglian AG, Amigoni S, Spadari G, Binelli D, Inzitari D. Efficacy and safety of nimodipine in subcortical vascular dementia: a randomized placebo-controlled trial. Stroke. 2005 Mar;36(3):619-24. doi: 10.1161/01.STR.0000155686.73908.3e. Epub 2005 Feb 3.
• Background Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
• Background Poggesi A, Salvadori E, Pantoni L, Pracucci G, Cesari F, Chiti A, Ciolli L, Cosottini M, Del Bene A, De Stefano N, Diciotti S, Dotti MT, Ginestroni A, Giusti B, Gori AM, Nannucci S, Orlandi G, Pescini F, Valenti R, Abbate R, Federico A, Mascalchi M, Murri L, Inzitari D. Risk and Determinants of Dementia in Patients with Mild Cognitive Impairment and Brain Subcortical Vascular Changes: A Study of Clinical, Neuroimaging, and Biological Markers-The VMCI-Tuscany Study: Rationale, Design, and Methodology. Int J Alzheimers Dis. 2012;2012:608013. doi: 10.1155/2012/608013. Epub 2012 Apr 8.
• Salvadori E, Poggesi A, Donnini I, Rinnoci V, Chiti G, Squitieri M, Tudisco L, Fierini F, Melone A, Pescini F, Pantoni L. Efficacy and Safety of the Association of Nimodipine and Choline Alphoscerate in the Treatment of Cognitive Impairment in Patients with Cerebral Small Vessel Disease. The CONIVaD Trial. Drugs Aging. 2021 Jun;38(6):481-491. doi: 10.1007/s40266-021-00852-8. Epub 2021 Apr 15.
• Salvadori E, Poggesi A, Donnini I, Rinnoci V, Chiti G, Squitieri M, Tudisco L, Fierini F, Melone A, Pescini F, Pantoni L. Association of nimodipine and choline alphoscerate in the treatment of cognitive impairment in patients with cerebral small vessel disease: study protocol for a randomized placebo-controlled trial-the CONIVaD trial. Aging Clin Exp Res. 2020 Mar;32(3):449-457. doi: 10.1007/s40520-019-01229-z. Epub 2019 May 30.

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